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Independent Statistical Analysis 

Independent Statistical Analysis
Manuscript Preparation

Cheryl Iverson

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Subscriber: null; date: 22 June 2018

Independent Statistical Analysis

UPDATE: The requirement for independent statistical analysis in industry-sponsored or industry-analyzed studies published in JAMA has been discontinued. This change was made July 10, 2013.

For industry-sponsored studies in which the statistical analysis was conducted only by statisticians employed by the sponsor, some journals, such as JAMA and several of the Archives Journals, require that data analysis be conducted by an independent statistician at an academic institution. If issues regarding the analysis should emerge, the academic institution provides an additional level of oversight independent of the commercial sponsor. This independent analysis should be conducted using the raw data set, and the results of that analysis should be the findings that are published in the manuscript. Some journals, such as JAMA, specify whether compensation was received for conducting the independent statistical analysis. (See also 5.5.5, Legal and Ethical Considerations, Conflicts of Interest, Requirements for Reporting Industry-Sponsored Studies, and Fontanarosa et al.10)

Independent Statistical Analysis: Independent statistical review of the data included in this analysis was performed by Stuart Pocock, PhD, and Duolao Wang, both of the London School of Hygiene and Tropical Medicine.

Independent Statistical Analysis: The accuracy of the data analysis was independently verified by Yingbo Na, MSc, and Martin Fahy, MSc, both from the Cardiovascular Research Foundation, an affiliate of Columbia University, who received the entire raw database and replicated all the analyses that were reported in the accepted manuscript. No discrepancies were discovered. Neither Mr Na nor Mr Fahy nor the Cardiovascular Research Foundation received any funding for this independent statistical analysis.

Independent Statistical Analysis: All study data were transferred from Sanofi-Aventis to the Department of Medicine at St Luke's–Roosevelt Hospital Center for independent analysis by Stanley Heshka, PhD. Statistical reanalysis of the raw data was performed by Dr Heshka. There were no discrepancies between the reanalysis and the original interpretation of the results and conclusions. In lieu of financial compensation for Dr Heshka's time and effort in performing the statistical analysis, an unrestricted educational grant from Sanofi-Aventis was given to the Obesity Research Center at St Luke's–Roosevelt Hospital Center, New York, New York.

Independent Statistical Analysis: Christopher E. Minder, PhD, professor of medical statistics at the University of Bern, Bern, Switzerland, and Peter Jüni, MD, senior lecturer in clinical epidemiology at the University of Bern, received a complete copy of the raw data from Cordis Corporation and performed an independent statistical analysis. They received no compensation for this work and had no conflicts of interest, not receiving any type of payment, equity, or reimbursement from either of the companies manufacturing the stents compared in the trial. They confirmed that they were able to replicate the analyses of the primary angiographic and secondary clinical outcomes reported in the manuscript and that they consider the analyses to be appropriate.

Independent Statistical Analysis: All study data were transferred from Hoffman–La Roche to the Department of Statistics at the British Columbia Children’s Hospital for independent reanalysis. Statistical reanalyses of the raw data were performed by Ruth Milner and Victor M. Espinosa, MSc. There were only minor discrepancies between the reanalysis and the original interpretation of the results and conclusions. When there was a discrepancy, Dr Chanoine included the results from the reanalyses performed at the British Columbia Children’s Hospital.

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